Notified Body Lloyd’s Register Quality Assurance (LRQA) announced on June 13, 2019, that it will be withdrawing services relating to the Medical Devices Directive (93/42/EEC) (MDD) and the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD) as well as its application to become a Netherlands-based EU Notified Body for the new Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). All its clients have now been informed and LRQA is working with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to assist clients holding certification with LRQA for the MDD and IVDD to transfer to an alternative service provider. According to Medtech Insight, LRQA’S clients have only been given 90 days’ notice.
The Association of British HealthTech Industries (ABHI) has recommended its members who are LRQA’S clients to speak with LRQA as a matter of urgency to ensure that products are not disadvantaged and will be actively engaged with the MHRA through the transfer process. LRQA will continue to offer ISO 13485 and Medical Device Single Audit Program (MDSAP) third party certification and medical devices-related training. Please click here to access the official statement from LRQA.
Notified Bodies and increased demand
LRQA’s announcement comes against a backdrop of regulators, Notified Bodies and companies facing challenges to be ready for the MDR and IVDR, alongside uncertainties associated with Brexit. The withdrawal of LRQA increases the stress across the entire medical devices sector: LRQA’s clients must source an alternative Notified Body; Notified Bodies in turn are struggling to recruit talent to meet growing demand; and LRQA’s traditional role managing a substantial proportion of currently CE-certified IVDs creates a void in both capability and capacity. In fact, during an interview at MedCon 2019, Bassil Akra of TÜV SÜDstated that “IVD is going to be the biggest big bomb that we will see in the next two years“, referring to a substantial deficit of Notified Bodies for IVDs (under the current IVDD, only approximately 20% of IVDs require a Notified Body, compared to almost 80% under the IVDR). There are also growing worries as to which entity will take responsibility for providing post-market services to medical devices that have conformity assessment certificates signed by LRQA.
According to TEAM-NB, the industry association of EU notified bodies in the medical device and IVD sphere, Notified Body activity has increased 30% over the past year as companies seek to recertify medical devices already placed on the market. By way of background, the MDR, which will become fully applicable on May 26, 2020, includes a derogation extension which allows companies to continue placing certain medical devices certified under the MDD for up to four years after the MDR’s full application (i.e. up to May 26, 2024) if the Notified Body conformity certificate remains valid. As such, the backlog for medical devices to be recertified under the MDD has continued growing, as companies see the derogation as a means to extend the time a product can remain on the market before becoming fully complaint with the MDR.
Statistics from TEAM-NB also show an overall rise in full-time equivalent employees working at 23 Notified Bodies over the past year, though still remaining below (by approximately 30%) the total number TEAM-NB members believe is required in order to meet industry demand. Swiss Notified Body QS Zurich AG has announced that it will not pursue designation under the MDR, although EN ISO 13485 will remain. Regulatory Focus has reported that the medical device department of QS Zurich AG will be closed at the end of October, with the company citing its commercial view that the cost of investment for the MDR is too high for such a small Notified Body. Last month, the Spanish Agency of Medicines and Medical Products (AEMPS) announced its decision to officially turn away new (and certain existing) clients, demonstrating the extent of challenges facing the sector characterised by high workload. In its announcement, the AEMPS stated that it had to suspend taking new work in order to complete conformity assessments under the MDD by the May 2020 deadline, posing a significant problem for Spanish companies as AEMPS is the only Spanish Notified Body.
On a related note, the substantial increase in demand for Notified Bodies services has generated fears of auditor burnout from the constant learning curves and increased workload.
Brexit and becoming MDR/IVDR-ready
With LRQA’s departure, only three UK notified bodies remain: BSI UK, SGS UK and UL International. BSI UK has proactively sought to prepare itself and its clients, having obtained Notified Body status under the current directives and, in relation to the MDR and IVDR, having receiving designation under the MDR and awaiting the outcome of its IVDR application. BSI’s Dutch counterpart has also received designation under the existing directives and submitted applications for the MDR and IVDR. On the contrary, there remains little communication from the two other UK Notified Bodies.
With the possibility of a no-deal Brexit still on the table, UK-centric Notified Bodies face an uncertain outlook. For clients, some have chosen to minimise risk by moving to alternative Notified Bodies while others continue to hope for a more positive Brexit. The MHRA has stated that under a no-deal Brexit, CE-marked medical devices from EU27 Notified Bodies will be recognised while those from UK Notified Bodies will not. Similarly, the EU Commission has emphasised that under a no-deal Brexit, EU27 countries will not recognise products with certificates from UK Notified Bodies. Industry has remained vocal about concerns of whether capacity for the necessary services is sufficient to ensure existing products are recertified in time to remain on the market. Only two Notified Bodies (BSI UK and TÜV SÜD) have obtained Notified Body designation under the MDR.
View from the EU
During a recent meeting of the EU’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), 20 Member States voiced their concerns about preparedness for the MDR and IVDR’s implementation, demonstrating the elevated political status of the issue and the critical need to mitigate the situation. A new Commission Factsheet has also conceded that there may be issues along the supply chain during the transition period, with the possibility that some devices “may become temporarily unavailable.” Earlier this month, the European Commission published a communication on the “State of play of preparations” in regards to Brexit, including updates on the Notified Body issues (please refer to page 5). While the European Commission recognises that achieving full compliance by the deadline for Brexit will require substantial work, it believes that the Article 50(3) extension should allow for the full transfer of certificates and the adaptation of product labels.